Archived updates for Friday, December 30, 2005

Topical Application Did Not Anticipate Sunburn Treatment

In Perricone, M.D. v. Medicis Pharmaceutical Corp. (Fed. Cir. December 20, 2005) the court agreed that claim 9 of U.S. Patent No. 5,409,693 was invalid for obviousness-type double patenting in view of claim 1 of U.S. Patent No. 5,574,063, but left open the possibility of remedying the problem with a terminal disclaimer two years after the lower courts holding of invalidity.

Claim 1 of the ’693 patent recited:

1. A method for treating skin sunburn comprising topically applying to the skinsunburn a fatty acid ester of ascorbic acid effective to solubilize in thelipid-rich layers of the skin an amount effective to scavenge therefrom freeradicals present as a result of transfer of energy to the skin from theultraviolet radiation which produced said sunburn.

while claim 9 of the ’063 patent recited:

9. A method for the treatment of skin damaged or aged by oxygen-containing freeradicals or oxidative generation of biologically active metabolites whichcomprises topically applying to affected skin areas a composition containing aneffective amount of an ascorbyl fatty acid ester in a dermatologicallyacceptable, fat-penetrating carrier such that the ester is percutaneouslydelivered to lipid-rich layers of the skin.

Circuit Judge Rader opinion agreed with the district court that the "effective to solubilize" language in claim 1 meant the "dermatologically acceptable fat-penetrating carrier" in claim 9. The court also reasoned that since sunburn is a species of skin damage, there was no error in the district court’s determination that the earlier species (sunburn treatment) rendered the later genus (skin damage treatment) claims invalid under non-statutory double patenting.

Finally, and contrary to the suggestion by the district court, the PatentAct and PTO rules support the filing of a terminal disclaimer even afterissuance of the second patent. See 35 U.S.C. § 253 (2000) ("[A]ny patentee . . .may disclaim or dedicate to the public the entire term, or any terminal part ofthe term, of the patent granted . . . ."); 37 CFR § 1.321(a) (incorporating thelanguage of § 253). The district court’s focus on In re Goodman, 11 F.3d 1046,1052 (Fed. Cir. 1993) (explaining that a terminal disclaimer can overcome adouble patenting "rejection") seems to have led to its conclusion that aterminal disclaimer cannot be filed for an issued patent to overcome invaliditybased on double patenting. The commentary from In re Goodman arose in thecontext of ex parte prosecution, a setting not applicable to this case. Anapplicant must always overcome every rejection to gain issuance of a patent.Accordingly, the pre-issuance timing requirement of a terminal disclaimer toovercome a double patenting rejection does not dictate a prohibition onpost-issuance terminal disclaimers. A terminal disclaimer can indeed supplant afinding of invalidity for double patenting. See Applied Materials, Inv. v.Semiconductor Materials Am., Inc., 98 F.3d 1563, 1577 (Fed. Cir. 1996) ("Forobviousness-type double patenting, [the improper extension of the statutoryterm] problem can sometimes be avoided for co-owned patents . . . through theuse of a terminal disclaimer."). This record, however, does not include anyevidence of a disclaimer even though the district court invalidated the claimsover two years ago. Thus, while Dr. Perricone might still file a terminaldisclaimer to overcome prospectively the double patenting basis for invalidity,this court makes no determination about the retrospective effect of such aterminal disclaimer.

With regard to anticipation, the court also held that the general disclosure of a similar lotion for "topical application" was insufficient to suggest the specific application to "treating skin sunburn."

The issue is not, as the dissent and district court imply, whether Pereira’s lotion if applied to skin sunburn would inherently treat that damage, but whether Pereira discloses the application of its composition to skin sunburn. It does not.

This court explained in Catalina Marketing International, Inc. v. Cool Savings.com, Inc. that a patent to an apparatus does not necessarily prevent a subsequent inventor from obtaining a patent on a new method of using the apparatus. 289 F.3d 801, 809 (Fed. Cir. 2002). New uses of old products or processes are indeed patentable subject matter. See 35 U.S.C. § 101 (2000) (identifying as patentable "any new and useful improvements" of a process, machine, manufacture, etc.); In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986) (principles of inherency do not prohibit a process patent for a new use of an old structure). That principle governs in this case as well.

Claim 1 of the ’693 patent recites a new use of the composition disclosed by Pereira, i.e., the treatment of skin sunburn. The district court’s inherent anticipation analysis for this claim contains a flaw. The disclosed use of Pereira’s lotion, i.e., topical application, does not suggest application of Pereira’s lotion to skin sunburn. In other words, the district court’s inherency analysis goes astray because it assumes what Pereira neither disclosed nor rendered inherent. Because Pereira does not disclose topical application to skin sunburn, this court reverses the district court’s holding that Pereira anticipates claims 1-4 and 7 of the ’693 patent.

Like the district court, the dissent seems to ignore, or at least dismiss as "not substantial[]," the distinction between Dr. Perricone’s claimed method and Pereira’s disclosed method. Thus, the dissent characterizes both methods the same way: "Pereira describes not only the same product that is claimed in the sunburn patent, but also the same method of using it, i.e., topically applying it to the skin in anamount necessary to have beneficial effects on the skin." Unfortunately, thedissent can make that statement only by dismissing the explicit language of Dr.Perricone’s claimed method: "applying to the skin sunburn." Skin sunburn is not analogous to skin surfaces generally. Thus, there is an important distinction between topical application to skin for the purpose of avoiding sunburn, and the much narrower topical application to skin sunburn.

That distinction highlights the flaw in the dissent’s knee brace hypothetical,which suggests that a particular prevention method necessarily anticipates atreatment method. To use a more apt analogy, the disclosure that a sunburn canbe prevented by wearing a hat clearly does not anticipate a claim to thediscovery that one can treat an existing sunburn by putting on a hat. Thedissent attempts to bolster its analogy by comparing the mechanism underlyingits knee brace analogy to Dr. Perricone’s invention. With that comparison, thedissent drifts even farther from the facts of this case. The alleged anticipating reference here is Pereira, not Dr. Perricone’s own teachings.

Pereira is silent about any sunburn prevention or treatment benefits, not tomention the mechanisms underlying such uses. If Pereira did teach sunburnprevention, as well as the mechanism behind that prevention, those teachingsmight suggest that Dr. Perricone’s sunburn treatment claims would have beenobvious. However, those unrealized possibilities do not alter the analysis inthis case where Pereira does not disclose topical application to skin sunburn.

I know this sounds completely crazy but vapor rub is not just for colds anymore!! It is the greatest relief for sunburn I know of. I work with teenage girls, who are absolutely impossible when they get burned!! We use the vapor rub on their burnt skin and it takes out the itching, burning and stiffness.